Understanding immune responses in HIV-infected children treated early with antiretrovirals

Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms

This study is trying to understand how HIV-infected children who started treatment early can have negative test results for the virus by looking at their immune responses and other factors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 451 (estimated)
• Sex: All
• Sponsor: ANRS, Emerging Infectious Diseases (Government)
• Locations: 3 sites (Douala and 2 other locations)
• Trial ID: NCT06302933 on ClinicalTrials.gov

What this trial studies

This study aims to explore the mechanisms behind negative serologies in HIV-infected children who received early treatment with antiretroviral therapy. It involves a retrospective case-control analysis of existing data and a prospective cross-sectional study utilizing a newly created bio bank for additional measurements. The research focuses on immunological responses, viral load, and genetic factors to understand how these children maintain negative HIV serology results. The study is part of the ANRS-Pediacam cohort in Cameroon, which provides a unique opportunity to investigate these interactions.

Who should consider this trial

Good fit: Ideal candidates include HIV-infected children who have been treated early with antiretrovirals and have available plasma samples for analysis.

Not a fit: Patients who are not part of the ANRS-Pediacam cohort or those without available plasma samples may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of HIV in children, potentially enhancing treatment strategies.

How similar studies have performed: While similar studies have explored HIV treatment in children, this specific approach focusing on negative serologies and the associated mechanisms is relatively novel.

Eligibility criteria

Inclusion Criteria:

Case control study

* Children included and followed in the ANRS 12225 study - Pediacam III
* Having plasma samples in the bio bank during the above-mentioned periods Case:children with at least one negative HIV serology made by ELISA, permanent or transientduring follow-up.

Control (4 groups)

* HIV-infected children with positive serology and viral load (VL) \<400 copies /ml
* HIV-infected children with positive serology and VL ≥400 copies / ml
* HIV-uninfected children born to HIV-positive mothers
* HIV-uninfected children born to HIV-uninfected mothers Selection of cases and controls will be matched on gestational age (premature \<37, term ≥37 weeks) and year of birth (2007-2008 and 2009-2010).

Cross sectional study Inclusion criteria

* All children still followed in the ANRS - Pediacam III cohort
* Written consent of one of the parents or the guardian and assent of the child if aged ≥ 11 years and complete disclosure of HIV statusfor infected children for participation to the study.

Exclusion Criteria:

* Refusal by one of the parents or the guardian for the child's participation in the study
* No assent of the child (if aged ≥ 11 years and with complete disclosure of HIV status, for infected children)

Where this trial is running

Douala and 2 other locations

• Hôpital de Jour - Hôpital Laquintinie de Douala — Douala, Cameroon (Not_yet_recruiting)
• Unité Pédiatrique de Jour - Centre Mère et Enfant de la Fondation Chantal Biya — Yaoundé, Cameroon (Recruiting)
• Service de Pédiatrie - Centre Hospitalier d'Essos — Yaoundé, Cameroon (Recruiting)

Study contacts

• Study coordinator: Mathurin C Tejiokem, Doctor

Conditions HIV Infections